A Phase 2 Dose-finding Study of TAK-272 in Participants With Type 2 Diabetes Mellitus and Microalbuminuria

Inclusion Criteria

• In the opinion of the investigator or the sub-investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
• The participant is either male or female and aged 20 to less than 75 years at signing of informed consent.
• The participant is an early-stage nephropathy (Stage 2) patient with type 2 diabetes mellitus.
• Inpatient/outpatient: outpatient
• The participant is a patient with type 2 diabetes mellitus on a certain diet therapy and/or exercise therapy (if any).
• The participant has stability controlled blood glucose, blood pressure and lipid, and does not need any change in the drug and the dose of any antihypertensive, antidiabetic and antidyslipidemia or antihyperlipidemic drugs throughout the study period as judged by the investigator or the sub-investigator.
• The participant has urine albumin/creatinine ratio (UACR) of the first morning urine (the first urine immediately after rising prior to activities in standing position in the morning) is ≥30 to
• The participant received TAK-272 in a previous clinical study.
• The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent to participate under duress.
• The participant has a history of hypersensitivity or allergies to TAK-272, candesartan cilexetil and other renin-angiotensin system (RAS) inhibitors (angiotensin converting enzyme [ACE] inhibitors, angiotensin II receptor blocker [ARBs] or direct renin inhibitor [DRIs]).
• The participant needs to take the prohibited medications during the study period.
• The participant has hyperkalemia (e.g., serum potassium ≥ 5.0 mEq/L at the start of the pretreatment period (Week -8) and Week -4 or requiring regular use of a potassium adsorbent) or onset of hyperkalemia within 2 years prior to starting the pre-treatment period.
• The participant has at least class II hypertension (e.g., sitting systolic blood pressure [SBP] ≥160 mmHg or sitting diastolic blood pressure [DBP] ≥100 mmHg in the pre-treatment period) or malignant hypertension.
• The participant has a renal disease other than type 2 diabetic nephropathy (e.g., patients with renal sclerosis, acute or chronic glomerular nephritis, or polycystic kidney).
• The participant has bilateral or unilateral renal artery stenosis.
• The participant requires regular use of nonsteroidal anti-inflammatory drugs (excluding low-dose aspirin and locally-acting agents such as topical drugs) (e.g., rheumatoid arthritis patients, osteoarthritis patients, and low back pain patients).
• The participant has a history of any of the cardiovascular diseases listed below within 2 years prior to starting the pre-treatment period:
• Cardiac diseases: myocardial infarction, coronary arterial revascularization
• Cerebrovascular diseases: cerebral infarction (excluding lacunar infarction), cerebral hemorrhage, transient ischemic attack
• The participant has any of the cardiovascular diseases listed below:
• Cardiac diseases: angina pectoris, arrhythmia, and congested heart failure that requires medication
• Vascular diseases: arteriosclerosis obliterans with symptoms (e.g., intermittent claudication)
• The participant has a clinically significant hepatic disorder (e.g., either of alanine aminotransferase [ALT] or aspartate aminotransferase [AST] is ≥ 2.5 times the upper limit of normal at the start of the pre-treatment period (Week -8) or at Week -4).
• The participant has a complication of malignant tumor.
• If female, the participant is pregnant, lactating, or is intending to become pregnant before, during or within 1 month after participating in this study; or intending to donate ova during such time period.
• If male, the participant intends to donate spe